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CompletedNCT01162252Updated Aug 13, 2014

Improving Psoriasis Through Health and Well-Being

An interventional study of Mindfulness-Based Stress Reduction and Living Well in Psoriasis, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-13.

Sponsored by University of Rochester · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to examine and compare the effects of the Mindfulness-Based Stress Reduction (MBSR) program and the Living Well (LW) program on adults with psoriasis in terms of how these programs may affect their psoriasis, immune function, physical and emotional health, and well-being.

Read the detailed description

The study examines the effects of two eight-week programs (MBSR vs. LW) for disease processes in patients with psoriasis severity reporting moderate or higher perceived stress. The research will focus both on clinical measures of the disease state and overall well-being.

The Aims of our proposed intervention study are the following:

  1. To examine the effects of MBSR, versus the Living Well (LW) program, on (a) disease severity, immunological markers of inflammation, and keratinocyte proliferation, (b) psoriasis-related stress and perceived stress in general, and (c) anxiety and depression.
  2. To examine whether treatment effects of either program are moderated by personality traits, mindfulness, and age.
  3. To examine the effects of behavioral and psychological mediators on immune outcomes.
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Conditions studied

  • Psoriasis

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Keywords

  • psoriasis
  • mindfulness
  • MBSR
  • stress
  • living well
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 130 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18 and older
  • English speaking
  • Clinical diagnosis of psoriasis (active at initial visit)

Exclusion criteria

Exclusion Criteria:

  • currently receiving immunosuppressive therapy for cancer or for diseases unrelated to psoriasis (or \< 6 months post-chemo or radiation)
  • major, uncorrected sensory impairments
  • cognitive deficits (MMSE \<25, or deficits deemed significant enough to interfere)
  • severe cardiovascular disease
  • current alcohol abuse or non-alcohol psychoactive substance use disorders, psychotic disorders (current and lifetime), and current mood disorder with psychotic features.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
130 participants (actual)

Study arms

  • Active comparator
    Mindfulness-Based Stress Reduction

    Behavioral: Mindfulness-Based Stress Reduction

  • Active comparator
    Living Well

    Behavioral: Living Well

Interventions

  • BehavioralMindfulness-Based Stress Reduction

    The standardized Mindfulness-Based Stress Reduction (MBSR) program is the primary training tool used to enhance mindfulness. The eight-week-long MBSR program is designed to teach subjects how to develop their inner resources in the service of taking better care of themselves. MBSR training includes the learning and refining of a range of skills aimed at increasing relaxation and awareness of physical experiences and sensations related to physical symptoms, emotions, and thoughts. Special emphasis is placed on movement, meditation, and breathing.

    Also known as: MBSR

  • BehavioralLiving Well

    The Living Well (LW) program involves a series of informational presentations and group discussions on a variety of topics related to the promotion of health and well-being. The 8-week program is designed to provide participants with knowledge about ways to improve their physical and emotional health as a complement to traditional medical treatments.

    Also known as: LW

06

What researchers measure

Primary outcomes

  1. Psoriasis disease severity measured from biopsied tissue samples of psoriatic and nonpsoriatic skin.

    Psoriasis is assessed for keratinocyte proliferation including immunohistochemistry (for CD3, neutrophil elastase, keratin 6 and S100A7 markers) and quantitative real time polymerase chain reaction (qRT-PCR) to examine expression of mRNA for IFN-γ, TNF-α, IL-17A, and the shared p40 subunit of IL-12 and IL-23 (assessed pre \& post intervention).

    Time frame: 8 weeks

Secondary outcomes

  1. Immunological markers of inflammation measured from blood samples.

    Circulating cytokines IL-6, TNF-α, and IL-22 measured via enzyme-linked immunoassays (ELISA) on all blood samples (pre, mid \& post intervention plus follow-up).

    Time frame: 16 weeks

  2. Perceived Stress Scale (Cohen S., Kamarck T., & Mermelstein R. (1983))

    The 14-item Perceived Stress Scale (PSS) is used to measure the degree to which current life situations are appraised as stressful by a participant (assessed at pre, mid \& post intervention plus follow-up).

    Time frame: 16 weeks

  3. State-Trait Anxiety Inventory (Spielberger C.D., Gorsuch R.L., & Lushene R.E. (1970))

    The State-Trait Anxiety Inventory (STAI) consists of two, 20-item scales to distinguish between relatively recent, transitory "state anxieties", from more chronic or persistent "trait anxiety" (assessed pre, mid \& post intervention plus follow-up).

    Time frame: 16 weeks

07

Study locations

1 site
  • University of Rochester; University Dermatology Associates
    Rochester, New York 14623, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01162252
Lead sponsor
University of Rochester
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Responsible party
Jan Moynihan (Director, The Rochester Center for Mind-Body Research, University of Rochester) — Principal investigator
First posted
Jul 14, 2010
Start date
Mar 2010
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Aug 13, 2014

Study contacts

Jan A Moynihan, PhD
principal investigator · University of Rochester

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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